21 CFR 73.1646 - Bronze powder.

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§ 73.1646 Bronze powder.
(a) Identity.
(1) The color additive bronze powder is a very fine metallic powder prepared from alloys consisting principally of virgin electrolytic copper and zinc with small amounts of the virgin metals aluminum and tin. It contains small amounts of stearic or oleic acid as lubricants.
(2) Color additive mixtures for drug use made with bronze powder may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring externally applied drugs.
(b) Specifications. Bronze powder shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:
Stearic or oleic acid, not more than 5 percent.
Cadmium (as Cd), not more than 15 parts per million.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million
Aluminum (as Al), not more than 0.5 percent.
Tin (as Sn), not more than 0.5 percent.
Copper (as Cu), not more than 95 percent and not less than 70 percent.
Zinc (as Zn), not more than 30 percent.
Maximum particle size 45µ (95 percent minimum).
Aluminum, zinc, tin, and copper content shall be based on the weight of the dried powder after being thoroughly washed with ether.
(c) Uses and restrictions. Bronze powder may be safely used in color externally applied drugs, including those intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(d) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.
(e) Exemption from certification. Certification of the color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
[42 FR 33723, July 1, 1977]

Title 21 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2013-11-15; vol. 78 # 221 - Friday, November 15, 2013
    1. 78 FR 68713 - Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; confirmation of effective date.
      The effective date for the final rule published August 13, 2013 (78 FR 49117), is confirmed as September 13, 2013.
      21 CFR Part 73

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United States Code

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 73 after this date.

  • 2013-11-15; vol. 78 # 221 - Friday, November 15, 2013
    1. 78 FR 68713 - Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; confirmation of effective date.
      The effective date for the final rule published August 13, 2013 (78 FR 49117), is confirmed as September 13, 2013.
      21 CFR Part 73